Quality Assurance Engineer II

1 month ago

Spiddal, Ireland Integer Holdings Corporation Full time

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Act as the NPI QA representative on NPI Projects with responsibility to ensure compliance to regulatory standards and internal standardised procedures. Initiate / Approve Validation protocols and reports (IQ, OQ, PQ) Initiate / Approve Change requests. Participate / Lead Risk Analysis initiatives e.g., FMEA Support Notified Body / Regulatory Agency / Customer Audits Perform / Support Internal and Supplier Audits Collate and trend Key performance indicator data monthly Actively participate in Management Review & Compliance meetings Performs other related duties, as assigned

A degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 3 yrs. experience of working as a Quality Engineer within the Medical Device Industry.

Capabilities & Abilities:

Candidate must be highly motivated with excellent communication skills, proven ability to work as part of a team, can multi-task and with the ability to interface at all levels. Knowledge of Medical device Regulatory requirements (e.g., ISO13485, Cleanroom environment ISO14644) Quality Certification and Lead Auditor Certification while not mandatory would be an advantage. Experience of using Lean Manufacturing Tools and Techniques an advantage Motivated and can demonstrate the ability to be a self-starter. Good computer skills in usage of MS Office Suite - Microsoft word / Excel / PowerPoint Ability to work on own initiative as well as part of a team Knowledge of basic problem-solving skills. Good documentation skills with strict attention to detail Strong analytical, organisational, and influencing skills. Resilient to deal with challenging situations Capable of promoting change Self-aware / Optimistic / Empathetic

U.S. Applicants: EOE/AA Disability/Veteran

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